Alliance Statement on the Reintroduction of the Ensuring Pathways for Innovative Cures (EPIC) Act

Yesterday, Reps. Greg Murphy (R-NC), Don Davis (D-NC), and Richard Hudson (R-NC) introduced H.R. 1492 the Ensuring Pathways to Innovative Cures (EPIC) Act, a bipartisan effort to allow small-molecule treatments the same 13-year exemption period as biologics. Alliance for Aging Research President and CEO Sue Peschin, MHS, released the following statement:

The Alliance applauds Reps. Murphy, Davis, and Guthrie for introducing the EPIC Act. This bipartisan bill is essential for protecting older patients’ access to the most effective and convenient treatment options.

Most known medicines today are small-molecule drugs, which come in the form of pills, capsules, or tablets that your local pharmacy usually fills for pick-up or delivery. In most cases, patients can take a small molecule treatment at home with a glass of water. Large-molecule biologic medications are usually infused through an IV line that is put into a vein, or as an injection. Because most biologics require administration by a clinician at a doctor’s office or in a hospital outpatient setting, patients must schedule appointments to receive their medication and have transportation to get there. Once there, it can take anywhere from several minutes to hours to receive a biologic injection or infusion, depending on the medication.

Both small molecules and biologics have a vital role to play in the future of medicine. However, the question of what kind of treatments to pursue should depend on the science, not artificial incentive payment structures that favor one over the other. Yet, that’s what a provision of the IRA put in place. The Inflation Reduction Act exempted FDA-approved small-molecule drugs from price controls for just nine years, while giving large-molecule biologics 13 years of protection. This disparity has already led several major drug manufacturers to deprioritize small-molecule research and development in favor of biologics.

Creating disincentives for the development of one category of drugs over another without any medical or scientific rationale does not make sense. There is also an element of irony to steering the future of pharmaceutical development toward biologics, because small molecule drugs are in most cases less expensive for patients and more easily genericized than biologics, leading to greater adoption and lower long-term costs. To the extent biologics become more dominant due to the IRA, they will lead to lower adherence but still higher Medicare costs overall. 

The EPIC Act provides a straightforward fix to allow small-molecule treatments the same 13-year exemption period as biologics. This will level the playing field while maintaining the IRA’s goal of ensuring adequate incentives for new drug development. We thank Reps. Murphy, Davis, and Guthrie for their leadership on the EPIC Act, and urge Congress to pass it as soon as possible.